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CDER OPQ to Continue Some Remote Assessments

[ Price : $8.95]

The CDER Office of Pharmaceutical Quality 2022 annual reports touts how alternative review techniques aided regulatory decision-ma...

Marks Wants Project Orbis for Cell/Gene Therapies

[ Price : $8.95]

CBER director Peter Marks tells a conference he would like to see a Project Orbis-style multi-national effort to spur the developm...

FDA Learning to Combat Social Media Disinformation

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The Los Angeles Times says FDA is learning how to use social media to combat those promoting disinformation and denying science.

DoJ Collects $2.2 Billion in 2022 False Claims Actions

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The U.S. Department of Justice says over $2.2 billion was collected in settlements and judgments under the False Claims Act during...

Benefit-Risk is Top CBER Panel Issue: FDA

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A new journal article by CBER reviewers finds uncertainty about assessment of the safety profile as a top discussion item at 24 ad...

Hyperfine AI-Powered Software for MRI Cleared

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FDA clears a Hyperfine 510(k) for its upgraded Swoop AI-powered software for use with the Swoop Portable MR Imaging System.

Ocuphire Pharma NDA for Eye Dilation Reversal

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FDA accepts for review an Ocuphire Pharma NDA for Nyxol (phentolamine ophthalmic solution 0.75%) for treating pharmacologically-in...

Info Collection Revision on Advisory Committees

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Federal Register notice: FDA seeks comments on an information collection revision entitled FDA Advisory Committees; Information Co...

Repackaging Propofol During Covid Guide Withdrawn

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Federal Register notice: FDA announces the withdrawal of a guidance entitled Temporary Policy on Repackaging or Combining Propofol...

10% of FDA-approved Drugs Had Null Findings: JAMA

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A new JAMA research article finds that between 2018 and 2021, FDA approved 210 new drugs and 21 (10.0%) were approved based on piv...